N/A
N=18
Feasibility Study on the VERAFEYE System
Atrial Septal Defect · Atrial Fibrillation · Atrial Arrhythmia · Left Atrial Appendage Closure
Bottom Line
View on ClinicalTrials.gov: NCT05931835 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Physician Feedback on VERAFEYE System — 100; 100; 100; 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VERAFEYE System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LUMA Vision Ltd.
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physician Feedback on VERAFEYE System |
100; 100; 100; 100; 100; 100 | — |
Summary
The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure.
Results from this study will be used to guide development and refinement the VERAFEYE System. The study is not designed to collect data for product approval and as such does not have a safety or efficacy endpoint.
Eligibility Criteria
Key Inclusion Criteria
- Subject is 18 to 80 years of age at the time of consent
- Subject is scheduled to undergo a standard of care, de-novo catheter-ablation procedure to treat typical AFL or AF; or left atrial appendage (LAA)/ atrial septal defect (ASD) closure procedure
- Subject is able to understand and willing to provide written informed consent
Key Exclusion Criteria
- Any of the following within 6 months prior to enrolment:
- Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
- Thromboembolic event (stroke), transient ischemic attack (TIA) or neurological disturbances
- Myocardial infarction
- Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
- Dilated or hypertropic cardiomyopathy
- Any planned surgical or endovascular intervention within 30 days before or after the ablation, or LAA/ASD closure procedure.
- Any of the following cardiac conditions:
- New York Heart Association (NYHA) class IV
- Left ventricular ejection fraction (LVEF) 40 kg/m2
- Body weight < 50kg
- Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the ablation, or LAA/ASD closure procedure)
- Life expectancy less than 12 months
- Subjects who are currently enrolled in another study
- Subjects with a thrombus or pericardial effusion detected in the LA/LAA during standard of care imaging
Data sourced from ClinicalTrials.gov (NCT05931835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.